Uptravi (selexipag) has been approved by the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension (PAH), a disabling lung disease that often leads to death or the need for lung transplant.
PAH is high blood pressure that affects arteries that connect the lungs and heart. It causes the heart to work harder, resulting in shortness of breath and limiting the ability to exercise, the FDA said Tuesday in a news release.
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Uptravi, among a class of drugs called oral IP prostacyclin receptor agonists, relaxes and opens blood vessels, easing the elevated pressure, the agency said.
The drug was evaluated in clinical trials involving more than 1,150 adults with PAH. Trial participants who took the drug did so for an average of about a year and a half. The drug was found to limit worsening of the disease and reduce the need for hospitalization.
Uptravi's most common side effects included headache, diarrhea, jaw pain, nausea, muscle pain, vomiting, pain in the arms and legs, and flushing.
The drug is marketed by San Francisco-based Actelion Pharmaceuticals.
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